STN EN ISO 13408-2
| Označenie: | STN EN ISO 13408-2 |
| Platnosť: | Platná |
| Počet strán: | 50 |
| Jazyk: |
EN
|
| Listinná verzia: | 18,90€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
| Slovenský názov: | Aseptické spracovanie výrobkov na zdravotnú starostlivosť. Časť 2: Sterilizujúca filtrácia (ISO 13408-2: 2018) |
| Anglický názov: | Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
| Dátum vydania: | 01. 09. 2018 |
| Dátum zrušenia: | |
| ICS: | 11.080.01 |
| Triediaci znak: | 85 6537 |
| Úroveň zapracovania: | idt EN ISO 13408-2:2018, idt ISO 13408-2:2018 |
| Vestník: | 08/18 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 13408-2:2011-10 (85 6537) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. This document is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). This document is not applicable to high efficiency particulate air (HEPA) filters. This document does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. |
| Náhľad normy: | Náhľad normy (PDF) |